Regulatory Affairs Manager

Introduction to role:

Are you ready to lead the charge in transforming breakthrough science into life-altering solutions? As a Regulatory Affairs Manager, you'll be at the forefront of delivering rapid and global approvals for Oncology products. Your expertise will guide the planning, coordination, and execution of regulatory submissions, ensuring that life-changing treatments reach patients efficiently. You'll be empowered to innovate, taking smart risks and breaking barriers to uncover new regulatory pathways. Join us in making a tangible impact on patients with unmet needs across the globe!

Accountabilities:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
  o Submission delivery strategy of all dossiers and all application types per market and/or region.
  o Review of documents (e.g., response documents, study protocols, PSRs, etc.).
  o Analysis of regulatory procedures and special designations used during development, authorizations, and extension of the product.
• Use and share best practices when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, execute, and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance, and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross-functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs, and/or alliance partners where relevant.
• Provide coaching, mentoring, and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Essential Skills/Experience:
Minimum Requirements – Education and Experience
• Relevant University Degree in Science or related discipline
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• General knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience
• Regulatory experience
• Managed regulatory deliverables at the project level
• Thorough knowledge of the drug development process
• Knowledge of AZ Business and processes

Skills and Capabilities
• Excellent written and verbal communication skills
• Cultural awareness
• Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
• Proficiency with common project management (e.g., MS Project) and document management tools
• Ability to work independently and as part of a team
• Influencing and stakeholder management skills
• Ability to analyze problems and recommend actions
• Continuous Improvement and knowledge sharing focused

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, innovation is at our core. We thrive in an inclusive environment that encourages collaboration across global teams. Our diverse knowledge fuels creativity, allowing us to take smart risks and develop modern approaches that drive efficiency. With a rich pipeline offering exposure to the complete drug delivery process, you'll have opportunities to take on new challenges and be an agent of change. Here, your contributions are valued as we work together to bring life-changing medicines to people.

Ready to make a difference? Apply now to join our dynamic team!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.